Grupo Roche Syntex De Mixixo Sa
⚠️ Moderate Risk
FEI: 3004512630 • Ciudad De Mexico, Ciudad de Mexico • MEXICO
FEI Number
3004512630
Location
Ciudad De Mexico, Ciudad de Mexico
Country
MEXICOAddress
Cerrada De Bezares No. 9, Col. Lomas De Bezares, Miguel Hidalgo, Ciudad De Mexico, Ciudad de Mexico, Mexico
Moderate Risk
FDA Import Risk Assessment
This firm has a moderate history of FDA import refusals. Some attention may be warranted.
Statistics
Score Breakdown
How is this score calculated?
Proprietary Algorithm
- 40% Violation Severity — AI-assessed (1-10)
- 30% Refusal Volume — Logarithmic scale
- 20% Recency — Decays over 5 years
- 10% Frequency — Refusals per year
© ImportRefusal.com Original Analysis
Violation Summary
UNAPPROVED
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be a new drug within the meaning of Section 201(p) without an approved New Drug Application (NDA).
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 10/3/2011 | 62KAA10OMEPRAZOLE (ANTI-PERISTALTIC, ANTI-DIARRHEAL) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 3/14/2005 | 64HDA02GUAIFENESIN (EXPECTORANT) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 3/14/2005 | 62GCY91ETODOLAC (ANTI-INFLAMMATORY) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
Frequently Asked Questions
What is Grupo Roche Syntex De Mixixo Sa's FDA import refusal history?
Grupo Roche Syntex De Mixixo Sa (FEI: 3004512630) has 3 FDA import refusal record(s) in our database, spanning from 3/14/2005 to 10/3/2011.
What is an FEI number?
FEI stands for Firm Establishment Identifier. It's a unique number assigned by the FDA to identify establishments that manufacture, process, pack, or hold food, drugs, medical devices, or other FDA-regulated products. Grupo Roche Syntex De Mixixo Sa's FEI number is 3004512630.
What types of violations has Grupo Roche Syntex De Mixixo Sa received?
Grupo Roche Syntex De Mixixo Sa has been cited for 1 different violation type(s). Common FDA violations include adulteration (unsafe or unsanitary products), misbranding (incorrect or misleading labels), and regulatory non-compliance.
Where does this information about Grupo Roche Syntex De Mixixo Sa come from?
All FDA import refusal data for Grupo Roche Syntex De Mixixo Sa is sourced from the official FDA Data Dashboard (datadashboard.fda.gov), a public government database maintained by the U.S. Food and Drug Administration.
Data sourced from the FDA Data Dashboard, a public database maintained by the U.S. Food and Drug Administration.